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The HealthBeacon HB2 Sharps Bin is intended for use by a single patient in the home setting. The HealthBeacon HB2 Sharps Bin comprises an outer enclosure that remains in the home. The outer enclosure contains a replaceable, single-use sharps bin that is intended to provide a receptacle for used, contaminated medical sharps. The single-use sharps bin also acts as an enclosure during transport of the used sharps to ultimate disposal.

The HealthBeacon HB2 Sharps Bin device is the combination of the:

• . Outer Enclosure, which remains in the home, and
• The single use Inner Sharps Bin, which is disposed of, once full. .

The HealthBeacon HB2 Sharps Bin comprises:

• A custom-shaped sharps bin molded in puncture-resistant polypropylene . plastic.
• . An integral sliding and permanently locking lid to close over after use and prior to dispatch to the destruction facility.
• A custom enclosure (the "HealthBeacon HB2 enclosure") for the sharps bin. ● The HealthBeacon HB2 Enclosure provides:
  • o A neutral and attractive cover for the sharps bin whilst it is being used in a domestic environment.
  • o A double trap door access path to the sharps bin to prevent fingeraccess to the sharps bin and its contents of used syringes while in the Enclosure with the side door closed.
• o A counter of syringes being deposited that will give the user a warning when the sharps bin is getting close to full.

The HealthBeacon HB2 Sharps Bin is molded from 2mm (0.08 inch) polypropylene in 3 snap-together sections. The sharps bin door is a sliding door that once fully closed, locks and cannot be re-opened. The HealthBeacon HB2 Enclosure is a neutrally colored enclosure for the sharps bin. The enclosure is molded from ABS plastic and has interlocks so that the sharps bin can only be fitted in the correct orientation within the enclosure. The enclosure door flap lines up with the sharps bin opening, and there is a spring-loaded trap-door within the enclosure that prevents direct access into the sharps bin itself.

The HealthBeacon HB2 Enclosure has a small electronics module to count and record the used hypodermic syringes being deposited. The usage information is passed to a cloud-based tracking database to provide compliance information. The tracking database also provides prompts to the user on a display screen in the HealthBeacon HB2 Enclosure. The prompts inform the user when the next selfadministered injection is due and the injection site to be used, so that they are rotated in time and thus lower the chance of adverse reactions. The patient can also elect to have text message reminders sent their cell phone.

The HealthBeacon HB2 Enclosure is powered by a Medical Device Certified (to IEC60601-1) power supply. This supplies electrical power for the small electronic counter unit.

The provided FDA 510(k) summary (K172719) for the HealthBeacon HB2 Sharps Bin describes acceptance criteria through compliance with a consensus standard and specific performance tests. The document, however, does not contain information related to AI or machine learning models. Therefore, many of the requested fields regarding AI model testing (like expert adjudication, MRMC studies, standalone performance, training set details) are not applicable.

Here's the information based on the provided document:

Acceptance Criteria and Reported Device Performance

1. A table of acceptance criteria and the reported device performance

Explanation of Missing Information due to Device Type:

The HealthBeacon HB2 Sharps Bin is a physical medical device (a sharps container), not a software or AI-powered diagnostic/analytic tool. As such, the concept of "ground truth," "test sets," "training sets," "experts for ground truth," "adjudication," and "AI assistance" in the context of diagnostic accuracy, which are typical for AI/ML-based medical devices, do not apply to this submission. The "study" here refers to the physical and functional testing of the sharps bin.

Here's a breakdown of the remaining points, indicating N/A where not applicable to this physical device:

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

• Sample Size: Not explicitly stated in terms of a "test set" for diagnostic accuracy. The testing was done on the physical device itself (likely multiple units, but not quantified as a "sample size" in the AI/ML sense).
• Data Provenance: N/A for data provenance for diagnostic accuracy. The testing was conducted by an "independent testing laboratory" on the physical product to ISO standards.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• N/A: No expert review for diagnostic ground truth is applicable for this physical device. The "ground truth" here is the physical performance against engineering standards.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

• N/A: No adjudication method for diagnostic performance is applicable.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• No: This is a physical device, so no MRMC study involving human readers or AI assistance was performed.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

• N/A: This is a physical device; there is no algorithm or standalone performance in the AI/ML context. The closest analogy might be the usage counter working automatically (standalone) without human intervention, which was tested for accuracy.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• Engineering Standards/Physical Performance: The "ground truth" for this device's performance is adherence to the requirements of the ISO 23907:2012 standard and accurate counting functionality, as determined by laboratory testing.

8. The sample size for the training set

• N/A: There is no training set for an AI/ML model for this device.

9. How the ground truth for the training set was established

• N/A: There is no training set for an AI/ML model for this device.

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